Dan Schweitzer

Accomplished pharmaceutical quality leader with 25+ years of hands-on and strategic experience spanning Quality Assurance, Quality Control, Operations, and Engineering. Proven success in managing end-to-end quality systems, hosting regulatory and client audits, leading cross-functional teams, and driving compliance in fast-paced, FDA-regulated environments. Adept at building high-performance teams, culture reinforcement/rebuilding, reducing quality risks, and aligning quality strategy with business goals.

AREAS OF EXPERTISE

FDA & GMP Audit Readiness, Quality System Management (QMS), CAPA & Deviation Programs, Inspection Readiness & Remediation, Root Cause Analysis / Risk Mitigation, Cross-Functional Leadership, Change Control & Documentation, Regulatory Compliance (21 CFR Part 210/211), Performance & Metrics Management, Process Validation (IQ/OQ/PQ)